A prospective, multicenter, double blind, placebo controlled randomized clinical trial to evaluate efficacy and safety of Meniphib tablets in female patients suffering from premenstrual syndrome.

Bhargava Phytolab0 个研究点目标入组 100 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1)Subject is willing and able to give written informed consent
•2)Female subjects aged Ã¢â?°Â¥ 18 and Ã¢â?°Â¤ 45 years not attained menopause
•3)Subject having clinical diagnosis as per investigators judgment for Premenstrual Syndrome
•4)Subjects of childbearing potential should have a negative pregnancy test at Screening
•5)Female subjects of childbearing potential should be willing to practice appropriate birth control during the entire duration of the study
•Appropriate birth control is defined in the study as any medically recommended method (or combination of methods) except oral birth control pills as per standard of care
•6)Subject is willing, able and likely to comply with all study procedures and restrictions

•1)Subject is pregnant or breast-feeding at the time of screening, or planning
•to be pregnant during the study
•2)History of current or past Psychiatric Disorders
•3)History consistent with endometriosis
•4)Diagnosis of ill-defined, obscure pelvic lesions, particularly, undiagnosed ovarian enlargement, hepatic disease as manifested by medical history
•5)History of mammary carcinoma
•6)History of pulmonary embolism or phlebothrombosis
•7)Undiagnosed vaginal bleeding
•8)Subject suffering from porphyria
•9)Subject suffering from uncontrolled diabetes mellitus
•10)History of malignant melanoma
•11)Subject suffering from cholecystitis or pancreatitis
•12)Cardiovascular or renal disease
•13)Subject taking birth control pills will be excluded from the study.
•14)Subject taking diuretics prostaglandin inhibitors or pyridoxine (putative treatments for MRMD) will similarly be excluded from the study
•15)Subject taking psychotropic agents
•16)Subjects who had an administration of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial
•17)Any other condition that in the investigators judgment might interfere with study objectives

发起方

Bhargava Phytolab